NCT06547788

Brief Summary

Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR. The standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS). Previous studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
41mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

August 7, 2024

Last Update Submit

April 29, 2026

Conditions

Mitral RegurgitationMitral Valve DiseaseHeart Failure

Outcome Measures

Primary Outcomes (3)

  • Feasibility: recruitment rate

    Process, Resources, Management, Scientific

    30 Months

  • Feasibility: Success rate of intervention

    Process, Resources, Management, Scientific

    30 Months

  • Feasibility: Study follow-up rate and length

    Process, Resources, Management, Scientific

    30 Months

Study Arms (2)

Mitral valve repair with creation of an 8m inter-atrial shunt

EXPERIMENTAL
Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt

Mitral valve repair without a shunt

ACTIVE COMPARATOR
Other: Mitral valve repair with creation of an 8 mm inter-atrial shunt

Interventions

Mitral valve repair with creation of an 8 mm inter-atrial shuntOTHER

Mitral valve repair with creation of an 8 mm inter-atrial shunt

Mitral valve repair with creation of an 8m inter-atrial shuntMitral valve repair without a shunt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years of age
  • Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease
  • Planned surgical mitral valve repair
  • Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline
  • Pulmonary vascular resistance ≤ 4 Wood units

You may not qualify if:

  • Secondary causes of MR and mixed mitral valve disease
  • Infective endocarditis within 30-days
  • Any prior mitral valve intervention
  • Need for emergency intervention or surgery
  • Left ventricular ejection fraction 2+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Vincent Chan, Dr.

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenza Rahmouni El Idrissi, Dr.

CONTACT

613-696-7000krahmouni@ottawaheart.ca

Alice Black

CONTACT

613-696-7230alblack@ottawaheart.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 9, 2024

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2030

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)